Kelly Quesada's work experience is as follows:
1. Oxford Biomedica Solutions (2022 - Present)
- Senior Vice President responsible for Strategy, Program Management, Legal, IT, Quality, and Regulatory functions.
- Partnered with CEO on a $180 million deal that led to the formation of the Oxford Biomedica Solutions joint venture and built out G&A functions.
- Promoted from Vice President in July 2022.
2. Chief (2022 - Present)
- Member of the company.
3. Homology Medicines, Inc. (2018 - 2022)
- Vice President, Head of Quality (2020 - 2022)
- Built Quality organization, including Quality Assurance, Quality Control, Quality Systems, and Validation.
- Implemented GxP Quality Systems to meet regulatory requirements and ensure safety and quality of AAV gene therapy and gene editing products.
- Senior Director, Head of Quality (2018 - 2020)
- First Quality hire for Homology Medicines, Inc.
- Built Quality organization, including Quality Assurance, Quality Control, Quality Systems, and Validation.
- Implemented GxP Quality Systems to meet regulatory requirements and ensure safety and quality of AAV gene therapy and gene editing products.
4. Shire (2015 - 2018)
- Head of Global Supplier Quality Management (2016 - 2018)
- Led organization of 27 quality professionals across 11 global locations with responsibility for supplier quality management of 3,000 GMP/GDP suppliers.
- Integrated Supplier Quality Management program post major acquisition six months ahead of schedule.
- Led internal audit team responsible for GMP/GDP audits of over 60 Shire entities.
- Head of QA Engineering (2015 - 2016)
5. Amgen (2003 - 2014)
- Senior Manager - International Quality (2011 - 2014)
- Served as Quality Lead, responsible for product transfers/launches into Asia markets.
- Built quality system infrastructure that met local regulatory requirements, policies, standards, and procedures.
- Senior Manager - Equipment Validation (2007 - 2011)
- Leader of a team that supported the validation of facilities, utilities, and equipment.
- Responsible for the Validation program, including periodic monitoring and maintenance of procedures and master plans.
- Manager - Quality Control/Warehouse Validation (2005 - 2007)
- Validation Engineer - Quality Control/Warehouse Validation (2003 - 2005)
6. Baxter BioScience (1999 - 2003)
- Supervisor.
Kelly Quesada attended UCLA, but there is no information provided regarding the start and end years, degree obtained, or field of study.
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